Quality Manager, EMEA
Currently partnered with a rapidly growing company specialised in the manufacturing of unique e-cigarette products aiming to eliminate smoking globally. Currently one of the top U.S based vapour products. Since its inception of their U.K office in July 2018 this company have seen a growth from 3 to 100+ employees. As they continue to expand they are seeing increasingly positive sales figures along with exciting results in the market; approximately 64% of smokers using this product do not smoke cigarettes again.
Continuing on their mission to eliminate cigarettes and improve the lives of billions of smokers, this company are now looking to appoint a new Quality Manager EMEA based in the U.K to be the first in quality in Europe. First priority will be to establish and develop the quality function in Europe while simultaneously embedding strong links and relationships between the U.S / U.K business.
- Develops and implements the local procedures (if needed) for relevant QA elements across departments and manages compliance. These will include:
- Preparation and presentation of regional management review
- Subject matter expert and coach on CAPA
- Key contributor to audit preparation, conduct, and follow up
- Training of regional employees
- Special projects for the EMEA leadership team, or global quality projects
- Provide EMEA perspective to global quality teams and global perspective to EMEA
- Understands and assures conformance to regulations and quality procedures for applicable QA elements or departments. Serves as regional point person to ensure execution of global processes. These may include:
- Develop and execution of EMEA customer complaints process, in alignment with global company procedures
- Customer complaint intake and entry into complaint system; complaint product returns to US for tear-down analysis
- Manage quality aspects of product storage, movement, environmental conditions, traceability
- Recall/field action management and execution
- Manage the CAPA (corrective and preventive action) portfolio
- Manage quality audit program
- Interacts with regulators during inspections.
- May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
- Interacts frequently with internal direct reports, functional peers and senior management.
- Manages interactions with regulators and stakeholders to represent the company products, procedures and processes.
- Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
- Develops plans and ensures adherence to budget for projects in responsibility.
- Manages coaching, training and development of subordinates if applicable
Personal & Professional Qualifications:
- 8-10 years of experience in Quality, minimum 5 years of management experience.
- Familiarity with tobacco/nicotine product regulations and standards; medical device and drug products familiarity a plus
- Robust leadership and communication skills
- Strong analytical and problem solving skills
- Substantial interpersonal/ influencing / negotiation skills
- Solid project management skills
Education: Bachelor's degree required, Science or Engineering preferred